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To study the effect of drugs given directly into the arteries feeding the liver cancer along with heat induced changes on liver cancer outcome as assessed by Computed tomography.

Efficacy and Safety of Combined treatment of Locoregional therapy :DEB-TACE and RFA , compared with conventional TACE-RFA in management of Intermediate stage Hepato Cellular Carcinoma - Multicenter Randomised Controlled Trial. - HEPTACE

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046766
Enrollment
118
Registered
2022-10-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K768- Other specified diseases of liver

Interventions

Intervention1: 1]Drug eluting bead 2] Radiofrequency ablation: 1] 75mg doxorubicin loaded on 100-300 microgram Beads . 2] RFA for 8-10 minutes Intervention2: ARM 2 -residual tumor: In case of resid

Sponsors

Indian Council Of Medical Research
Lead Sponsor
MADRAS MEDICAL COLLEGE
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. BCLC stage B with Child Pugh A or B 2. Main portal vein patent 3. No extrahepatic spread 4. No previous treatment for Hepatocellular Carcinoma 5. Coagulation parameters suitable for TACE.

Exclusion criteria

Exclusion criteria: 1. Uncorrectable Coagulopathy 2. Refractory Ascites 3. Hepatic Encephalopathy 4. Esophageal/ Variceal bleeding 5. Allergic to contrast

Design outcomes

Primary

MeasureTime frame
1] modified Response Evaluation Criteria in Solid Tumors (mRECIST) used for response evalution 2]at 1,3,6,12 months after intervention by Triple phase CT /MRI scan.Timepoint: 12 months.

Secondary

MeasureTime frame
liver function tests Timepoint: 1,3,6,12 months after intervention

Countries

India

Contacts

Public ContactS Kalpana

Barnard Institute of Radiology, Madras Medical College,

kapudr@gmail.com9710342141

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026